FDA label 2ce55717-8ebd-b475-e063-6294a90ae968

openFDA label record#

This page contains supplementary openFDA label data. For the canonical label presentation, use the corresponding DailyMed Structured Product Label.

Verified complete openFDA source JSON (canonical bytes are SHA-256 checked before publication)

SPL set ID
9c8d1214-52b6-47db-92eb-943ffa7e97e3
SPL ID
2ce55717-8ebd-b475-e063-6294a90ae968
Version
6
Effective date
2025-01-29
Source export date
2026-09-28
Source partition
3
Source file
https://download.open.fda.gov/drug/label/drug-label-0003-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-09-28/fd09911bd1bc81f7f2faeb048e63855fe224e494376ae919a0035190e315c050/drug-label-0003-of-0014.json.zip
Source manifest SHA-256
cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
Import run
20260929T050834Z
Imported at
2026-09-29 05:20:42

Warnings cross-check#

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Warnings sections page 1 of 1 · 2 matching rows.

warnings

Warnings Sodium Chloride Injection, USP should be used with great care, if at all, in patients with congestive heart failure, servere renal insufficiency, and in clinical states in which there exist ederna with sodium retention. In patients with diminshed renal function administration of Sodium Chloride Injection, USP may result in sodium retention.

warnings and cautions

Directions for Use Warnings: Do not use plastic containers in series connections. Such use could result in air embolism due to residual air being drawn from the primary container before administration of the fluid from the secondary container is completed. To Open Tear overwrap down side at slit and remove solution container. Some opacity of the plastic due to moisture absorption during the sterilization process may be observed. This is normal and does not affect the solution quality of safety. The opacity will diminish gradually. Check for minute leaks by equeezing inner bag firmly. If leaks are found, discard solutions as sterility may be impaired. If supplemental medication is desired, follow directions below. Preparation for Administration 1. Suspend container from eyelet support. 2. Remove plastic protector from outlet port at bottom of container. 3. Attach administration set. Refer to complete directions accompanying set.

Adverse reactions cross-check#

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Adverse reactions sections page 1 of 1 · 1 matching rows.

adverse reactions

Adverse Reactions Reactions which may occur because of the solution or the technique of administration include febrile response, infection at the site of injection, venous thrombosis or phlebitis extending from the site of injection, extravasation, and hypervolemia. If an adverse reaction does occur, discontinue the infusion, evaluate the patient, institute appropriate therapeutic counter measures and save the remainder of the fluid for examination if deemed necessary.

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.